PREVENA™ CUSTOMIZABLE™ Prevena Customizable DressingRecalls & reported problems
Kci USA, Inc. · Prevena Customizable Dressing · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00849554000087), received between Aug 9, 2019 and Aug 9, 2019 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Necrosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2019 UPON DRESSING REMOVAL, THE PLASTIC SURGEON ALLEGEDLY OBSERVED BILATERAL NECROTIC OF THE AREOLA PAPILLARY COMPLEX NOTED AS BLACKENED ASPECTS OF THE AREOLAS. THE PLASTIC SURGEON SUBSEQUENTLY INSERTED A NEEDLE INTO THE PATIENT'S AREOLAS AND BLEEDING WAS OBSERVED DEMONSTRAING HOPE OF RECOVERING AREOLAS.
Patient problems: Necrosis
MAUDE report 8879659 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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